Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device magnetically maneuvered capsule endoscopy system
Definition A magnetically maneuvered capsule endoscopy system consists of an ingestible capsule and magnetic controller and is used for visualization of the stomach and duodenum. The ingestible capsule contains a camera that wirelessly captures images of the mucosa. The magnetic controller is used outside of the patient and is magnetically coupled with the capsule to control its location and viewing direction.
Product CodeQKZ
Regulation Number 876.1310
Device Class 2


Premarket Reviews
ManufacturerDecision
ANX ROBOTICA CORP
  SUBSTANTIALLY EQUIVALENT 2
ANX ROBOTICA CORP.
  SUBSTANTIALLY EQUIVALENT 2
ANX ROBOTICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ANX ROBOTICA, INC.
  GRANTED 1

-
-